Convex ostomy faceplate with floating flange and finger recess

ABSTRACT

An adhesive faceplate for detachable connection to an ostomy pouch is disclosed. The faceplate has an integrated convex pressure ring for promoting stomal protrusion and a so-called floating flange (i.e., coupling ring) for mechanical attachment to the mating coupling ring of an ostomy pouch. The convex pressure ring is provided with a deep annular recess behind the faceplate&#39;s coupling ring to accommodate a user&#39;s fingers during a coupling operation, thereby facilitating attachment of a pouch. The pressure ring also includes a thin, inwardly-extending connecting portion which is heat sealed to the backing layer of the faceplate&#39;s adhesive wafer and, when that backing layer is formed of a porous material, such heat seal effectively closes the pores of the backing layer in the area of the seal.

BACKGROUND AND SUMMARY

Ostomy Applicances having integrated convex pressure rings for promotingstomal protrusion are well known as disclosed, for example, in U.S. Pat.Nos. 4,973,323, 5,316,607, 4,834,731, 4,710,182, and Internationalpublished application WO95/24169. It is also known to provide two-pieceappliances with faceplates that have so-called floating flanges--thatis, flanges or coupling rings that are mounted for limited movementtowards and away from adhesive wafer components of the faceplates (seeU.S. Pat. No. 4,419,100). However, efforts to combine the floatingflange feature and convex pressure ring feature into a single faceplate,as disclosed in U.S. Pat. No. 4,834,731, have tended to result inrelatively complex constructions having multiple layers, plural seals,and requiring numerous manufacturing steps.

A main aspect of this invention lies in providing a relatively simplebut highly effective faceplate construction which has both a floatingflange and a convex pressure ring, and in which the convex pressure ringcontributes significantly in promoting ease of operation of the floatingflange. To that end, the pressure ring is provided on its distal orpouch-facing side with an axially-extending mounting rib. The end of ribis joined to the inner edge of a thin annular web, and the outer edge ofthe web is sealed to the faceplate's coupling ring. The pressure ringhas a deep annular recess located directly behind the coupling ring,making it easy for a user to insert his/her fingers behind the couplingring (i.e., between the coupling ring and the remainder of thefaceplate) during a coupling operation. The recess also has the effectof reducing the weight of the faceplate and rendering the pressure ringmore flexible and conformable in use than it would be if the recess wereabsent. At the same time, the pressure ring provides the faceplate withsufficient convexity and stiffness to press against the peristomal skinsurfaces and promote stomal protrusion when the appliance is worn.

The bodyside surface of the pressure ring is convex and is secured tothe backing layer of an adhesive wafer. Preferably, the pliant adhesivematerial of the wafer has particles of one or more hydrocolloidsdispersed therein and may be any of a variety of adhesive formulationsgenerally known as skin barrier compositions. Ideally, the backing layeris both porous and thermoplastic. Although the backing layer extendsinwardly all of the way to the stoma opening of the faceplate, thedanger of fluids wicking outwardly through the pores of the film orfabric is avoided because of an extended heat seal between the backinglayer and a thin, flexible inner portion of the pressure ring. Thefusion between the backing layer and pressure ring in the area of theannular heat seal obliterates the pores of the backing layer in thatarea, thereby closing off routes that might otherwise exist for theoutward migration of fluids when the appliance is used.

Other features, advantages and objects will become apparent from thespecification and drawings.

DRAWINGS

FIG. 1 is a plan view of a faceplate embodying the invention.

FIG. 2 is a side elevational view of the faceplate.

FIG. 3 is an enlarged cross sectional view taken along line 3--3 of FIG.1.

FIG. 4 is a fragmentary sectional view showing the wafer and pressurering in unconnected condition.

FIG. 5 is an enlarged fragmentary sectional view depicting the heat sealbetween the pressure ring and wafer.

FIG. 6 is a sectional view similar to FIG. 3 but showing use of thefinger recess when the faceplate is to be connected to a pouch.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

Referring to the drawings, the numeral 10 generally designates thefaceplate of a two-piece ostomy appliance. The other component of theappliance is a conventional pouch 11 with a coupling ring 12 indicatedin phantom in FIG. 3. Since the pouch component does not constitute anypart of this invention, further description is believed unnecessaryherein. However, reference may be had to U.S. Pat. No. 5,185,008 fordetails of the coupling system shown herein.

The faceplate 10 comprises a convex pressure ring 13, a faceplatecoupling ring 14, a connecting web 15, and an adhesive wafer 16.

The adhesive wafer consists essentially of two layers: a bodysideadhesive layer 17 and a pouchside backing layer 18 (FIG. 4). A thirdlayer in the form of a release sheet 19 is also provided to protect thebodyside surface of the adhesive layer prior to use. Release sheet 19may be formed of any suitable thermoformable plastic that is formulatedor treated for allowing it to be easily peeled from the bodyside surfaceof adhesive layer 17. Most advantageously, the release sheet 19 isformed in one piece so that it may be removed in its entirety in onepeeling step and, to facilitate such removal, a tab 19a projectsoutwardly beyond the edge of the adhesive layer as shown most clearly inFIGS. 1-4.

The adhesive layer may be composed of any adhesive suitable forattaching the faceplate to the peristomal skin surfaces of a patient.Particularly effective results have been achieved with skin-friendlyadhesives, commonly known as skin barrier materials, that have both wetand dry tack and contain hydrocolloids capable of absorbing fluids andswelling as they do so. The hydrocolloid particles, which may consist ofcarboxymethylcellulose, pectin, gelatin, karaya, or any other of avariety of hydrocolloids and superabsorbents known for use in skinbarrier formulations, are dispersed in a soft, pliant elastomericadhesive material such as, for example, polyisobutylene.

Backing layer 18 may be of thin, flexible, thermoplastic film or foam;however, it is especially desirable that it be composed of a porousthermoplastic film or fabric. Particularly effective results have beenobtained using a perforated polyethylene film that has a fabric-liketexture, but other soft breathable or non-breathable thermoplasticmaterials may be used.

The convex pressure ring 13 has a convex bodyside surface 13a and apouchside surface 13b from which an annular integral attachment rib 20projects (FIG. 4). The pressure ring has a thin flexible innerconnecting portion 21 that extends radially inwardly from the rib andterminates in a stoma-receiving opening 22.

Outboard of the rib 20 on the pouchside surface of the ring is a deepannular finger-receiving recess 23. The pressure ring continuesoutwardly, terminating in an outer connecting portion 24 that lies insubstantially the same plane as the end of rib 20 (FIG. 4).

The inner connecting portion 21 is heat sealed to the thermoplasticbacking layer 18 of the wafer 16 for the full radial extent of the innerconnecting portion, as shown most clearly in FIG. 5. In the heat sealzone 25, the pressure ring and backing layer are fused together in a waythat obliterates the pores of the backing layer when that backing layeris formed of a microporous material. The heat seal therefore not onlysecures the parts together but does so in a way that prevents thewicking or outward migration of fluids from about the stoma when thefaceplate is worn.

It is important that the inner connecting portion 21 of the pressurering be thin and flexible. When heat welded to the backing layer 18, thebacking layer and inner connecting portion should have a combinedthickness no greater than about 1.5 mm and, preferably, no greater than0.8 mm. As a result, the pressure ring and wafer maintain flexibilityinboard of rib 20 and are sufficiently thin as to be easily cut (withscissors) to enlarge the stoma-receiving opening of the faceplate whenthe appliance is being fitted on a patient.

As shown most clearly in FIG. 3, the outer connecting portion 24 of thepressure ring is heat sealed to the thermoplastic backing layer 18 ofthe wafer along annular heat seal zone 26.

The thermoplastic coupling ring 14 shown in the drawings is similar inconstruction and operation to the ring shown and described in U.S. Pat.No. 5,185,008, the disclosure of which is incorporated by referenceherein. It is to be understood, however, that coupling rings of othermechanical constructions might be used. In any case, it is essentialthat the diameter of the coupling ring 14 be greater than the diameterof rib 20. A thin, flexible, imperforate annular web 15 joins the two,with the inner edge 15a of the web being heat sealed to the end of therib 20 and its outer edge 15b heat sealed to coupling ring 14.

When the parts are so connected, web 15 and coupling ring 14 are aligneddirectly with finger-receiving recess 23. This allows the coupling ringto be urged away from the remainder of the faceplate simply by insertinga finger into the recess 23 as depicted in FIG. 6. When the couplingring is so displaced, it may be easily joined to the mating ring 12 of apouch simply by squeezing the two rings together between opposingfingers. The coupling rings are therefore joined together with far lesseffort than if the finger-receiving recess were absent.

While in the foregoing, I have disclosed an embodiment of the inventionin considerable detail for purposes of illustration, it will beunderstood by those skilled in the art that many of these details may bevaried without departing from the spirit and scope of the invention.

We claim:
 1. An adhesive faceplate for detachable connection to anostomy pouch, comprising a thermoplastic pressure ring having a convexbodyside surface and a pouchside surface with an annular mounting ribextending axially therefrom; a coupling ring having a diameter largerthan said rib and coaxial therewith; a thin annular web having an inneredge joined to said rib and an outer edge secured to said coupling ring;said pouchside surface of said pressure ring having an annular recessdisposed outwardly of said rib and aligned directly with said couplingring for receiving a user's fingers between said coupling and pressurerings; and a flexible adhesive wafer affixed to said bodyside surface ofsaid pressure ring for adhesive attachment of said faceplate toperistomal skin surfaces.
 2. The faceplate of claim 1 in which saidpressure ring includes a thin flexible inner connecting portionextending inwardly from said rib and defining a stoma-receiving opening;said wafer having an opening aligned with said opening of said pressurering and having a bodyside adhesive layer and a pouchside backing layerof stretchable, flexible thermoplastic material; said connecting portionof said pressure ring and said backing layer being welded together in acontinuous annular heat seal zone.
 3. The faceplate of claim 2 in whichsaid backing layer is formed of porous sheet material and is gas andliquid permeable except in said heat seal zone where the pores thereofare occluded by said weld.
 4. The faceplate of claim 3 in which thecombined thickness of said flexible backing layer and said innerconnecting portion of said pressure ring welded thereto does not exceedabout 1.5 mm.
 5. The faceplate of claim 2 in which said backing layer isthermoplastic film.
 6. The faceplate of claim 2 in which said backinglayer is thermoplastic foam.
 7. The faceplate of claim 2 in which saidpressure ring also has an outer connecting portion extending outwardlybeyond said recess; said outer connecting portion and said backing layerbeing welded together in a continuous heat seal zone.
 8. The faceplateof claims 1, 2 or 3 in which said adhesive layer of said wafer comprisesa pliant elastomeric adhesive material having particles of one or morehydrocolloids dispersed therein.